NCT03471351 is a Phase 1 clinical trial of Tenalisib in Classical Hodgkin Lymphoma, sponsored by Rhizen Pharmaceuticals SA.

Who is sponsoring NCT03471351?

NCT03471351 is sponsored by Rhizen Pharmaceuticals SA.

What drugs are being tested in NCT03471351?

Interventions in NCT03471351: Tenalisib, Pembrolizumab.

What condition does NCT03471351 study?

NCT03471351 studies Classical Hodgkin Lymphoma.

Is NCT03471351 still recruiting?

NCT03471351 is currently terminated. Last updated 27 December 2019.

Last reviewed 2019-12-27 · How we verify

NCT03471351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL

Terminated Phase 1 Last updated 27 December 2019

What this trial tests

Phase 1 trial testing Tenalisib in Classical Hodgkin Lymphoma in 2 participants. Terminated before completion.

Timeline

18 July 2018

Primary endpoint
13 February 2019

13 February 2019

Quick facts

Lead sponsor	Rhizen Pharmaceuticals SA
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	18 July 2018
Primary completion	13 February 2019
Estimated completion	13 February 2019
Sites	3 locations across United States

Drugs / interventions tested

Tenalisib — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Classical Hodgkin Lymphoma — all drugs for Classical Hodgkin Lymphoma →

Sponsor

Rhizen Pharmaceuticals SA — full company profile →

Who can join

18 and older, any sex, with Classical Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Macrophages as regulators of tumour immunity and immunotherapy.
DeNardo DG, Ruffell B. · · 2019 · cited 1903× · PMID 30718830 · DOI 10.1038/s41577-019-0127-6
Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Emerging role of PTEN loss in evasion of the immune response to tumours.
Vidotto T, Melo CM, Castelli E, Koti M, et al · · 2020 · cited 163× · PMID 32327707 · DOI 10.1038/s41416-020-0834-6
Macrophage-Mediated Subversion of Anti-Tumour Immunity.
Quaranta V, Schmid MC. · · 2019 · cited 69× · PMID 31331034 · DOI 10.3390/cells8070747
PTEN Alterations as a Potential Mechanism for Tumor Cell Escape from PD-1/PD-L1 Inhibition.
Cretella D, Digiacomo G, Giovannetti E, Cavazzoni A. · · 2019 · cited 63× · PMID 31500143 · DOI 10.3390/cancers11091318
Immune checkpoint inhibitors in lymphoma: challenges and opportunities.
Hatic H, Sampat D, Goyal G. · · 2021 · cited 50× · PMID 34277837 · DOI 10.21037/atm-20-6833
Small-molecule agents for cancer immunotherapy.
Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010

Verify or expand the search:

Other trials of Tenalisib

Trials testing the same drug.

NCT06189209 — Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) · Phase 2 · recruiting
NCT04204057 — Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) · Phase 2 · completed
NCT03770000 — Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lym · Phase 1, PHASE2 · completed
NCT03711604 — Compassionate Use Study of Tenalisib (RP6530) · Phase 1, PHASE2 · completed

Other recruiting trials for Classical Hodgkin Lymphoma

Currently open trials in the same condition.

NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers · Phase 1 · active not recruiting
NCT06848569 — Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study · Phase 2 · recruiting
NCT06563245 — Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment · Phase 2, PHASE3 · recruiting
NCT05934084 — Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors · NA · recruiting
NCT05900765 — A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma · Phase 2 · recruiting

Other Rhizen Pharmaceuticals SA trials

Trials by the same sponsor.

NCT06189209 — Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) · Phase 2 · recruiting
NCT05021900 — Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer · Phase 2 · completed
NCT05002868 — Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors · Phase 1 · completed
NCT05007236 — Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 · Phase 2 · completed
NCT04680429 — A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03471351 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rhizen Pharmaceuticals SA
Last refreshed: 27 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03471351.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing